A Study of LY4167586 in Participants With Obesity or Overweight Who Are Otherwise Healthy

A Phase 1, Randomized, Placebo-Controlled, Single Ascending Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4167586 in Participants With Obesity or Overweight Who Are Otherwise Healthy

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07225556

Enrollment

Registered

2025-11-06

Start date

2025-11-18

Completion date

2026-12-01

Last updated

2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Brief summary

The purpose of this study is to look at how safe and well-tolerated LY4167586 is in participants with obesity or overweight who are otherwise healthy. Blood tests will be performed to check how much LY4167586 gets into the bloodstream and how long it takes the body to eliminate it following a single administration. Participation in the study will last approximately 7 months.

Interventions

DRUGLY4167586

Administered SC

DRUGPlacebo

Administered SC

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Participant must be 21 for Singapore site * Have a body mass index (BMI) between 27.0 kilogram per square meter (kg/m²) and 35.0 kg/m², inclusive * Have had a self-reported stable weight for 3 months prior to screening (less than approximately 5 percent \[%\] body weight change)

Exclusion criteria

* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study drug, or of interfering with the interpretation of data. * Is an individual of childbearing potential (IOCBP)

Design outcomes

Primary

Measure	Time frame	Description
Number and Incidence of Serious Adverse Events (SAEs)	Baseline to study completion (up to 29 weeks)	A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary

Measure	Time frame	Description
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax)	Predose on Day 1 through end of the Follow-up Period (Week 25)	PK: Cmax of LY4167586
PK: Time of Maximum Drug Concentration (tmax)	Predose on Day 1 through end of the Follow-up Period (Week 25)	PK: tmax of LY4167586
PK: Area Under the Concentration Versus Time Curve (AUC)	Predose on Day 1 through end of the Follow-up Period (Week 25)	PK: AUC of LY4167586

Countries

Singapore, United States

Contacts

STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026